Thursday, May 9, 2013

As I do my ongoing research and participate with scientists in discussions about the industry and all the facets within it, I find these claims all the time, "our products are FDA approved" or "our products are manufactured by an FDA certified lab."

So naturally, the consumer who may not realize the facts of the situation take it at face value. I know this because I have had many customers contact me and pose these questions. Or they will share their stories of past products, stating they knew they were safe because they were supposedly FDA approved.

I can't even count the websites within my industry that make this claim as well.

Let Me Make Things Perfectly Clear And Dispel This Myth

The FDA is solely responsible for protecting the public health by regulating human and animal drugs, biologics, medical devices, food and animal feed, cosmetics, and products that emit radiation.

The FDA does NOT approve or certify any cosmetic or skincare products on the market today. The only ingredients in cosmetics that are FDA approved are the colorants that go into products. And the FDA has a separate division for this.

They DO NOT approve or certify manufacturing facilities, and they DO NOT approve or certify labs.

But They Are FDA Registered

As an FDA registered facility ourselves, this does not mean the FDA endorses, approves or certifies our products are the best or safe or proved promise of efficacy. We are not manufacturing drugs here. This is of course a voluntary program and as a cosmetic formulator, I believe this is vital to credibility of the products we provide as complying with all FDA regulations....such as GMP (Good Manufacturing Practices).

The FDA DOES inspect facilities to make sure they (we) are complying with those GMP guidelines because if they do discover violations, it can be grounds for being shut down or penalized.

FDA registration however, is mandatory for owners and operators of domestic or foreign food, drug, and most device facilities are required to register with FDA. Blood and tissue facilities also must register with the agency.

What The FDA Does Approve Or Certify

Mammography facilities must be FDA certified. Mammography facilities are required to display their FDA certificates where patients can see them. The certificate indicates that the facilities have met stringent standards and can provide quality mammography.

New drugs and biologics must be proven safe and effective to FDA's satisfaction before companies can market them. In fact this is where some of the confusion occurs and the truth gets stretched. Since the FDA does not develop or test products, they rely only on FDA experts which review the results of the private laboratory, animal, and human clinical testing done by manufacturers, and if FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.

So even though a manufacturer gets a product approved under these stringent regs, it does not make their facility an FDA certified lab. So I guess if one were looking for a lab to produce a product for them, then a track record of sorts on the labs products gaining approval from the FDA is beneficial as showing a standard of producing exceptional quality using GMP.... but that is as far as it goes.

Colorants for purposes of cosmetics........

As I stated earlier about colorants, the FDA does approve these and they are found in food, dietary supplements, drugs, cosmetics, and some medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the agency, and each must be used only in compliance with its approved uses, specifications, and restrictions.

In the approval process, FDA evaluates safety data to ensure that a color additive is safe for its intended purposes. This is why some of our colorants used are clearly noted that they are not safe for lips, such as Ultra Marines, so these should never be found in a lip color. If they are found in a lip color for sale then these would be determined as a violation and deemed unsafe for use.

As a whole FDA does not, nor ever has approved cosmetics such as perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations.

FDA field investigators inspect cosmetic companies, examine imports, and collect samples for analysis. FDA may take action against non-compliant products, or against firms or individuals who violate the law. This can also be said for making medical or anti-aging claims since then this would put the product into the DRUG category whereby requiring compliance with the approval process, anything short of this is a violation of FDA regulations.

Side Note: Some may think Sunscreens are approved by the FDA since they are considered OTC drugs. However, the FDA does not approve the sunscreen per se, but only the ingredients used to create sun protection are approved. It is still up to the company to validate their SPF levels as proof of efficacy, followed by submission of their testing to the FDA for approval, and then comply with all drug monograph labeling practices.

So always be suspicious of labels that try to claim FDA Approval. False and misleading statements are a violation and should be reported to the FDA when located, whether at the point of sale, such as websites, or on the product packaging itself.

This Is My Favorite Most Of All

"Our products are certified organic by the FDA and ECOCERT."

FDA does not define or regulate terms such as “organic” and “natural.” However, the U.S. Department of Agriculture (USDA) does regulate the use of the term “organic” when used in terms of agricultural ingredient marketing. There are also private organizations that certify “natural” and other claims; however, these organizations are in no way affiliated with FDA. ECOCERT and NOP (National Organic Program) would be an example of these organizations, however separate and apart from the FDA.

Also, remember that all cosmetics are required to be safe, regardless of the sources of their ingredients. An ingredient’s source does not determine its safety. Even natural ingredients can cause potential harm to a person if they should be allergic to it... in science and chemistry, nothing is perfect absolutely.

However, even products that are created under these organic certifications are still regulated by FDA, and are subject to their jurisdiction under the law. The USDA requirements for the use of the term “organic” are separate from the laws and regulations that FDA enforces for cosmetics. Cosmetic products labeled with organic claims must comply with both USDA regulations for the organic claim and FDA regulations for labeling and safety requirements for cosmetics.

In A Nutshell

So there you have it, the facts surrounding the bogus claims of "FDA Approved" or "FDA Certified" made by many cosmetic and skincare companies....and I have seen them on doctors websites turned skincare entrepreneur, making the offense worse since one would think they should know better. Unfortunately, this just doesn't exist in reality.....and of course one more thing that those within our industry stoop to just to try and compete in the beauty products market.

Hopefully, a time will come when this practice of deceiving customers will stop and all of us will be on a level playing field helping customers make educated decisions based on the true science and benefits that any one product may provide.

1 comment:

Apparently a glitch occurred in our comment section since we never delete comments, so I apologize for the problem we experienced briefly.

Donna Maria @ Indie Business commented: What a super post, Katherine. Thank you for sharing this with your customers and also making it available to the public on the Web so that manufacturers and consumers alike can see these things spelled out clearly and in layperson's terms. I will be sure to share this post so other Indie Business members and friends can benefit!

My Response: Share away! I hope others will find it helpful and this will clear up any confusion some may have that are walking that fine line of mislabeling or providing misleading information. We really do need to all be on the same page with this.

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